BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Access PCT, Access PCT Calibrators

    K Number: K192271 · Decision Nov 26, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    3
    Applicant Total
    270
    Review Days
    96

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    Basic Information

    Device Name
    Access PCT, Access PCT Calibrators
    K Number
    K192271
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3215
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    August 22, 2019
    Decision Date
    November 26, 2019
    Product Code
    PTF
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PTF Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

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